Do drug makers use an FDA safety program to thwart generics?

24-07-2014 WSJ Pharmalot BlogComments (0)

GenericsUSA

Over the last couple of years, though, generic drug makers claim they have increasingly been denied access to samples of brand-name drugs needed to conduct product testing in order to win FDA approval for their copycat versions. Brand-name drug makers, they allege, have resisted providing samples or restricted distribution by arguing that REMS programs do not permit such sharing. A new study claims that brand-name maneuvering is costing the U.S. health care system $5.4 billion on drug spending.

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